随着临床实践及现代科技的发展,经典的随机对照试验已不能满足人们需要,尤其是在中医药研究领域。而与此同时,旨在获得更加符合临床实际证据的真实世界研究(Real World Study,RWS)因具有更广泛的应用前景而受到越来越多的关注。本文简述...随着临床实践及现代科技的发展,经典的随机对照试验已不能满足人们需要,尤其是在中医药研究领域。而与此同时,旨在获得更加符合临床实际证据的真实世界研究(Real World Study,RWS)因具有更广泛的应用前景而受到越来越多的关注。本文简述了RWS的概念及RWS需较大的样本量以覆盖较全面的人群、无严格的纳入及排除标准、根据患者的实际病情和意愿选用不同措施而不采用随机分配的方式、关注的结局是与临床密切相关的终点事件及患者的生活质量、需要长期的随访观察等特点,分析了RWS在临床中的应用现况,以此为基础,对RWS在中医药临床研究中的应用进行了展望,以期为中医药研究者们提供新的思路。展开更多
Background:Although breast-conserving surgery is one of the standard treatments for breast cancer,few studies have assessed its recent implementation in China.We aimed to clarify the current real-world status of breas...Background:Although breast-conserving surgery is one of the standard treatments for breast cancer,few studies have assessed its recent implementation in China.We aimed to clarify the current real-world status of breast-conserving surgery in China.Methods:This cross-sectional survey relied on data collected by the Chinese Society of Breast Surgery(CSBrS)to examine patients who underwent this surgery between January 2018 and December 2018.The survey was conducted using a uniform electronic questionnaire to collect information,including clinical and pathological data on these patients.Results:Overall,4459 breast-conserving surgeries were performed in 34 member units of CSBrS,accounting for 14.6%of all breast cancer surgeries performed in these units during the study period.In patients who underwent breast-conserving surgery with information on tumor size available,more than half(61.2%)of the tumors were smaller than 2 cm in diameter,and only 87(3.2%)tumors were larger than 4 cm in diameter.Among patients who underwent breast-conserving surgeries,457(10.2%)patients received neoadjuvant therapy before the surgery.Among patients with a reported margin width,34(2.0%)patients had a margin of≤2 mm,and 1530(88.2%)of them had a margin of>5 mm.Conclusions:This study demonstrated the rates of breast-conserving surgery in member units of the CSBrS,and introduced the characteristics and surgical margins of patients who underwent this surgery.This information helps describe the real-world status of breast-conserving surgery in China.展开更多
文摘随着临床实践及现代科技的发展,经典的随机对照试验已不能满足人们需要,尤其是在中医药研究领域。而与此同时,旨在获得更加符合临床实际证据的真实世界研究(Real World Study,RWS)因具有更广泛的应用前景而受到越来越多的关注。本文简述了RWS的概念及RWS需较大的样本量以覆盖较全面的人群、无严格的纳入及排除标准、根据患者的实际病情和意愿选用不同措施而不采用随机分配的方式、关注的结局是与临床密切相关的终点事件及患者的生活质量、需要长期的随访观察等特点,分析了RWS在临床中的应用现况,以此为基础,对RWS在中医药临床研究中的应用进行了展望,以期为中医药研究者们提供新的思路。
基金This work was supported by grants from the National Key Research and Development Program of China(Nos.2016YFC0901300 and 2016YFC0901302)。
文摘Background:Although breast-conserving surgery is one of the standard treatments for breast cancer,few studies have assessed its recent implementation in China.We aimed to clarify the current real-world status of breast-conserving surgery in China.Methods:This cross-sectional survey relied on data collected by the Chinese Society of Breast Surgery(CSBrS)to examine patients who underwent this surgery between January 2018 and December 2018.The survey was conducted using a uniform electronic questionnaire to collect information,including clinical and pathological data on these patients.Results:Overall,4459 breast-conserving surgeries were performed in 34 member units of CSBrS,accounting for 14.6%of all breast cancer surgeries performed in these units during the study period.In patients who underwent breast-conserving surgery with information on tumor size available,more than half(61.2%)of the tumors were smaller than 2 cm in diameter,and only 87(3.2%)tumors were larger than 4 cm in diameter.Among patients who underwent breast-conserving surgeries,457(10.2%)patients received neoadjuvant therapy before the surgery.Among patients with a reported margin width,34(2.0%)patients had a margin of≤2 mm,and 1530(88.2%)of them had a margin of>5 mm.Conclusions:This study demonstrated the rates of breast-conserving surgery in member units of the CSBrS,and introduced the characteristics and surgical margins of patients who underwent this surgery.This information helps describe the real-world status of breast-conserving surgery in China.